US7244245B2 - Sheath device with dressing for prevention of pneumothorax. - Google Patents

Abstract

A sheath device comprises a substantially rigid elongated body adapted to receive a chest tube. The body includes a first end and a second end, flexible seal at the first end, and an air-impermeable flexible joint at the second end. A base having a first side and a second side is provided at the joint, wherein the first side is connected with the flexible joint and the second side includes an adhesive for securing the base to a patient's chest. A method of preventing pneumothorax in a patient having a chest tube removed comprises attaching the sheath device to the patient's chest at the time of the chest tube placement, later withdrawing the chest tube into the airtight chamber of the sheath, and sealing the sheath device. Removing the base and flexible joint of the sheath device from the body of the sheath device leaves an air-impermeable dressing on the patient's chest.

Description

This application is a continuation of application Ser. No. 09/689,545, filed Oct. 12, 2000, now U.S. Pat. No. 6,569,121.

BACKGROUND OF THE INVENTION

In a healthy person, the pleural chest cavity is generally an airtight, airless environment. During normal respiration, the contraction of the diaphragm increases the volume of the cavity, which in turn decreases the pressure therein and causes the lungs to expand. Normally, air cannot enter or escape the pleural cavity.

Patients who have fluid or air in this cavity may be treated by inserting a chest tube into the pleural cavity to drain this fluid or air. The chest tube typically comprises a plastic tube having drainage holes at its tip and in a section of its sidewall and is inserted through an incision in the wall of the patient's chest. Ordinarily, the tube is connected to a collection container for holding the drained fluids. When the cavity of a given patient has been drained and the underlying cause of the fluid buildup has been addressed, the chest tube must be removed from the patient. This is done conventionally by withdrawing the tube and suturing the incision closed. In some patients, most notably children, no suturing is done, and petroleum jelly is used to seal the opening around the chest tube during the withdrawal of the tube. A gauze dressing is then placed over the incision and secured to the skin. However, if an inspiration occurs while the tube is partially pulled or before the incision is sealed, air can enter the pleural cavity due to the negative pressure therein.

Pneumothorax, or the passage of air into the pleural cavity, is undesirable because it allows the chest cavity to lose pressurization and decreases the expansion capability of the lungs. Complications of pneumothorax can include the collapse of part or all of a lung caused by pressure from free air in the chest cavity between the two layers of the pleura, which are thin membranes that cover the lung. Further complications associated with pneumothorax include respiratory failure and lung infection. Hospitalization and treatment with special equipment following minor surgery may be necessary for patients who suffer from pneumothorax.

Pneumothorax risk while removing a chest tube from a patient may be minimized by limiting the amount of air that can enter the chest cavity during and after removal of the tube. Ordinarily, upon removal of the chest tube from the body, a doctor or technician will attempt to hold the opening into the chest closed with the hand while undertaking to suture or bandage the opening. In many cases, however, the dressing placed over the opening is not completely air impermeable, or the attendant may have difficulty holding the opening closed while suturing the opening. While the pressure leaks may be minimal, these procedures are cumbersome to undertake, and the relatively minor leaks may compromise pressurization within the chest cavity and cause the patient some distress while breathing. More seriously, dressings or sutures may become completely undone, thereby allowing the cavity to depressurize more rapidly. This would, of course, more severely affect the ability of the patient to respirate properly and complicate a pneumothorax condition.

SUMMARY OF THE INVENTION

In accordance with the present invention, a combination sheath and dressing device is provided for use in assisting in the removal of chest tubes from patients and the dressing of the tube incision in the chest. The device allows a chest tube to be removed without allowing air into in the chest cavity during the removal process, and facilitates the healing of the chest incision after the tube is removed. The device preferably includes an air-impermeable base dressing which is placed over the opening into the chest cavity. The base is connected to a tubular housing for receiving a conventional chest tube. The housing, which is attached to the dressing via a flexible boot structure, is used to allow some movement of the chest tube within the housing while maintaining pressure in the chest cavity. The flexible boot allows the dressing to be closed without compromising the pleural airspace.

In one aspect of the invention, a sheath device comprises a substantially rigid elongated body adapted to receive a chest tube. The body includes a first end and a second end, flexible seal at the first end, and an air-impermeable flexible joint at the second end. A base having a first side and a second side is provided at the joint, wherein the first side is connected with the flexible joint and the second side includes an adhesive for securing the base to a patient's chest. The base provides an air-impermeable connection between the flexible joint and a patient's chest cavity.

In another aspect of the invention, a method of preventing pneumothorax in a patient having a chest tube removed is provided. The method includes the steps of attaching to the patient's chest an air-impermeable sheath device having a body, a joint, and a base such that the flexible joint and the base are removable from the body, and removing the chest tube through the sheath device. After the chest tube is pulled out of the patient's chest and before the chest tube is entirely removed from the sheath device, a portion of the device is sealed and separated, thereby leaving an air-impermeable dressing over the patient's chest.

In still another aspect of the invention, a sheath device for use on a patient having a chest tube inserted into the patient's chest cavity includes a substantially rigid, hollow, air-impermeable body configured to fit snugly around a chest tube. The body includes a first end and a second end, seal at the first end of the body, an air-impermeable flexible sealable joint at the second end of the body, and a base. The base includes a first side and a second side, and the first side is connected with the flexible joint. The second side includes an adhesive for securing the base to the patient's chest, and the base provides an air-impermeable connection between the flexible joint and the patient's chest cavity. The flexible joint and base together may form an air-impermeable dressing on the patient's chest.

The present invention provides the foregoing and other features, and the advantages of the invention will become further apparent from the following detailed description of the presently preferred embodiments, read in conjunction with the accompanying drawings. The detailed description and drawings are merely illustrative of the invention and do not limit the scope of the invention, which is defined by the appended claims and equivalents thereof.

BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS

Note that for purposes of clarity, the drawings herein are not drawn to scale.

FIG. 1 is a perspective view of the sheath device of the present invention along with a chest tube for use therewith;

FIG. 1A is a view of the sheath device shown inFIG. 1 with the chest tube removed;

FIG. 1B is a rear view of the sheath device shown inFIG. 1A;

FIG. 2 is a perspective view of the sheath device of the present invention installed on the chest wall of a patient, and including a chest tube inserted therein;

FIG. 3 is a perspective view of the sheath device as shown inFIG. 2 in a retained position against the patient's chest;

FIG. 4 is a perspective view showing the chest tube being removed manually from the sheath device of the present invention;

FIG. 5 is a cut-away side view of the sheath device ofFIG. 1 showing the chest tube removed from the cavity of the patient but retained within the sheath device of the present invention;

FIG. 6 is a side view showing the sheath device of the present invention being temporarily sealed with a clamp;

FIG. 7 is a side view similar to that ofFIG. 6 showing the clamped section of the sheath device being separated from the body portion of the sheath device and the chest tube;

FIG. 8 shows the sealed joint and dressing portion of the sheath device attached to the patient and configured as a wound dressing;

FIG. 9 is a side view of a second embodiment of the sheath device of the present invention showing an adhesive area within the joint portion of the device; and

FIG. 10 is a side view of a third embodiment of the invention showing a stop means integrated therein.

DETAILED DESCRIPTION

Referring toFIG. 1, asheath device5 is shown with aconventional chest tube2 for placement therein. Thesheath device5 has abody10, aseal15, a joint20 and abase25. Preferably, thebody10 is substantially rigid. By “substantially rigid”, it is meant that thebody10 does not collapse onto itself when air passes through it at the pressures commonly associated with the thoracic cavity. Thebody10 is preferably formed from an air-impermeable material. By “air-impermeable”, it is meant that air cannot pass through the material, or, that if it can, it passes through so slowly and at such a minimal volume that it does not interfere with the purpose of the present invention. While it is preferred that thebody10 is substantially rigid, a portion of thebody10 may comprise a flexible portion so that a portion of thechest tube2 may be gripped by the user while still within thebody10.

Preferably, thebody10 is made of a clear or generally opaque medical-grade, sterile plastic. For reasons that will become clear below, it is also preferable that thedistal end7 of the chest tube be at least partially visible through the wall of thebody10. Thebody10 is elongated in a tubular shape, and adapted to fit around thechest tube2. Any dimensions are acceptable, so long as they do not interfere with the ability of thebody10 to fit around thechest tube2 and for thechest tube2 to be slidably retained therein. The interior of thebody10, along with thebase25 and the joint20, preferably enclose an interior, continuous airspace.

Theseal15 is preferably a substantially air-impermeable, elastomeric O-ring. A small quantity of sterile lubricant may be used to facilitate slidable movement of the chest tubes through the seal and within thebody10. Preferably, the interior diameter of the O-ring will deform slightly to allow thechest tube2 to slidably pass within the opening of theseal15. Theseal15 is preferably mounted to the interior of thebody10 adjacent thedistal end17 of thebody10. The interior portion of theseal15 preferably extends past the sidewalls of thebody10 and partially into the interior13 of thebody10. This ensures that air cannot escape at the interface between thedistal end17 and theouter wall3 of thechest tube2 when it is received within thebody10. Note that theseal15 may be located within thebody10 in a position other than near thedistal end17. For example, it may be located within thebody10 towards the middle of thebody10 to allow a greater slidable area for the chest tube and relative to thebody10.

Thechest tube2 preferably comprises aforward portion4 that defines a plurality ofdrainage holes4aaround thesidewall3 of thetube2. The drainage holes4aassist in the collection of fluid from the thoracic cavity area and allow the fluid to drain towards arearward portion6 of thetube2. Acoupling8 is preferably provided on the distal end of therearward portion6 to connect thechest tube2 to adrainage tube9. Thedrainage tube9 is in turn preferably connected to acollection container13 for holding the collected chest fluid.

The joint20 is preferably a flexible and air-impermeable boot that joins thebody10 with thebase25. By “flexible” it is meant that the material forming the joint20 can be bent with minimal effort. The joint includes ridged annular raisedportions21 along its walls to provide a corrugated structure that allows the joints to be bent to approximately 90° without closing off its internal throughgoing airspace. The joint20 is attached at one end with thebase25 and attached at the opposing end with thebody10. Preferably, the joint20 is constructed of a latex material having a wall thickness sufficient to support its annular corrugated structure. Other, non-corrugated configurations may of course be utilized to lend flexibility to the structure of the joint20. In a first embodiment, the joint20 betweenbody10 and thechest tube2 may be manually sealable, as described below.

As shown inFIG. 1a, thebase25 includes afront side25athat is sealed to the joint20. Thebase25 is preferably molded using a planar, substantially rigid plastic material having a slightly convex curve toward the mounted joint20. As shown inFIG. 1b, the base25 preferably defines a second, slightlyconcave side25bthat carries an attachment mechanism for attaching thesheath5 to a patient. Preferably, the attachment mechanism is a medically acceptable adhesive deposited along arim30 of thebase25. The adhesive allows an airtight seal between thesheath5 and the skin of the chest wall. The attachment mechanism can also include staples, stitches, and any other sealable, substantially air-impermeable attachment mechanism known in the art.

FIG. 2 shows thesheath device5 mounted to thechest wall60 of thepatient100. As shown in the drawing, thebase25, in particular, is mounted via an adhesive on theunderside25bof the base25 to the skin of thepatient100 along thechest wall60. Underneath the plastic film of thebase25, the incision opening62 into the thoracic cavity or pleural airspace of thepatient100 is visible. Theincision62 allows thechest tube2 to penetrate into the chest cavity of the patient. Typically, the forward portion of the chest tube containing the plurality ofdrainage openings4ais inserted into the interior of thechest cavity60 to collect fluids within the cavity. In such cases, the chest tube is usually inserted so that the forward portion is completely enclosed within the patient, and no openings are exposed on the outside of thechest incision62. In most applications herein, the sterilizedsheath device5 is placed onto thechest wall60 of thepatient100 at the time thechest tube2 is inserted into theincision opening62. This is preferred because thechest tube2, thesheath body10, the underside of thebase25, and the field around the incision opening62 are sterile only at that time.

With thechest tube2 positioned properly within the chest cavity, thesheath device5 may be bent flush with the patient'schest60 as shown inFIG. 3. Strips ofadhesive tape64 may be used to adhere thesheath5 to thepatient100 while allowing the chest cavity to drain through the tubes. In this position, thechest tube2 is partially protected within thebody10 and secured against thechest60 by thetape64 and the adhesive underneath thebase25. With thesheath device5 andchest tube2 in this secured position, the intubated patient has a reduced risk of the chest tube being accidentally pulled out of the chest.

As shown inFIG. 3, it is preferable to prevent movement of thechest tube2 relative to thesheath device5 by wrapping a piece ofadhesive tape7 around the distal end of thebody10 and a rearward portion of thechest tube2 as shown. Thetape7 may also be wrapped around the interface between thechest tube2 and the distal end of thebody10 to seal the interface and to further prevent compromise of the airspace within thesheath device5. By securing thesheath device5 and thechest tube2 in the position shown inFIG. 3 and as described herein, a significant advantage of the invention becomes apparent, in that it becomes unnecessary to secure thechest tube2 directly to thepatient100 using several large sutures. Such suturing to the skin of thepatient100 is common practice using the prior art.

Using the present embodiment of the invention, achest tube2 may be removed from the patient's chest cavity without compromising the vacuum of the pleural airspace. The undertaking of the removal procedure is shown in the perspective drawing ofFIG. 4. As shown in the Figure, amedical technician110 preferably removes thechest tube2 from thepatient100 by grasping thesheath body10 using ahand110aand the chest tube using ahand110b. During the removal procedure, thetechnician110 preferably holds thebody10 stationary relative to the patient so that undue pressure is not exerted against the base25 to compromise the adhesive relationship between the base25 and thepatient100. At the same time, thetechnician110, using thehand110b, withdraws thechest tube2 from thepatient100 by pulling thetube2 outwardly from theincision62 and relatively out through the distal end of thebody10 of thesheath device5. The O-ring seal15 maintains the vacuum pressure within the chest cavity of thepatient100 by maintaining the pressure within theairspace13awithin thebody10.

Thechest tube2 is fully withdrawn from thepatient100 when the distal end of thetube7 is completely removed from theincision62 as shown in the side view ofFIG. 5. It is important that theforward portion4 of thechest tube2 not be withdrawn past theseal15. If any of theopenings4ahave passed the seal15 (in this embodiment just past adjacent thedistal end17 of the sheath body5) the continuous airspace within thechest tube2 and the patient's pleural cavity will be compromised to atmospheric pressure outside of the patient.

Once thechest tube2 is sufficiently withdrawn from thepatient100, the flexible joint20 may be temporarily sealed off by asurgical hand clamp90 as shown inFIG. 6. Thehand clamp90 preferably includes relativelyflat clamping jaws91 that pinch the walls of the flexible joint20 together to prevent air from escaping from the pleural cavity. Once the flexible joint20 is so sealed, the remaining portion of thesheath device5 may be separated from the clamped portion of theflexible seal20. This may be accomplished by using a knife or scissors to cut theflexible seal20 along theline93 as shown inFIG. 6. In the alternative, the flexible joint20 may be pre-perforated or include a self-separating tab pull along the approximate area of the severingline93 to simplify separation of thesheath device5 from the clamped area.

Once the severingline93 has been cut or otherwise separated, the flexible joint20 will comprise twosections20band20a. The remainingportion20aincluding a portion of the flexible joint20, thesheath body10, and thechest tube2 and its related components as separated from the clampedportion20bmay be discarded as shown inFIG. 7. The airspace within the pleural cavity and within theportion20bof the flexible joint remains sealed by theclamp jaws91, which leaves the medical technician's hands free to more permanently seal theportion20bof the flexible seal. Preferably, the technician can sterilize the outer portion of theflexible seal20 and run a surgical stitch or use adhesive to close the severedportion20cto the right of theclamp jaw91. In the alternative, the technician may use adhesive, tape, a heat-sealing apparatus or other known method to provide an airtight seal adjacent to theedge portion93 of the severedportion20c.

After theedge93 is sealed, theclamp90 may be removed, thereby leaving the sealedportions20band20cof the flexible joint intact on thebase25, which in turn remains attached to thepatient100. The incision (not shown) will remain surrounded by the sterile environments of thebase25 and theflexible seal20bfor healing. In this configuration, thebase25 and remaining portions of theflexible seal20band20ctogether comprise a sterile dressing over the incision. This remaining configuration is shown inFIG. 8. Advantageously, thechest tube2 has been removed in an airtight and sterile environment, reducing the risk of pneumothorax and infection.

In anotherembodiment300, the joint320 may be automatically self-sealable, as depicted inFIG. 9. As shown in the Figure, the interior of the joint320 includes self-sealing adhesivestrips having portions340aand340b. Preferably, the adhesive portions of thestrips340aand340bgenerally face each other. After the chest tube is removed past the joint320 into thebody310, theadhesive strips340amay be pinched manually ontoadhesive strip340bwithin the joint320 from the outside of the joint320, creating an air-impermeable seal in the joint320. Thebody310 and a portion of the joint320 may then be separated from the sealed dressing portion as described above. As in the above-described embodiment, the automatically sealable embodiment provides a mechanism with which a chest tube is removed in an airtight environment, thereby significantly reducing the risk of pneumothorax.

In another embodiment of the invention, to further speed chest tube removal while preventing the accidental compromise of pleural pressure during the procedure, a stop means is provided on either the chest tube and/or the body of the sheath device to prevent the tube from being pulled too far out of the sheath device. This alternate embodiment is shown inFIG. 10. In this embodiment, thesheath device410 is shown in a side cutaway view having achest tube402 inserted therein. The stop means is structured as a raisedannular ring470 joined substantially around the circumference of a portion of therear portion403 of thetube402. Stop faces472 are fixed to theinner wall405aof thesheath body405, and extend toward the internal axial airspace of thebody405. In the present embodiment, the stop faces472 may comprise an annular ring positioned on theinner wall405aor upstanding faces of other shapes. The faces472 contact therear face470aof theannular ring470 as thetube402 is pulled outwardly from thesheath body410, and thereby prevent thechest tube402 from being pulled past the contact point between theface470aand thefaces472. This prevents theforward portion404 of thechest tube402 from being pulled past the O-ring seal415 and thereby compromising the airspace in the pleural cavity to atmospheric pressure. With the chest tube and sheath device in this configuration, both of these main components may be packaged and provided to medical personnel connected together in this fashion.

It should be appreciated that the present invention is capable of being incorporated in the form of a variety of embodiments, only a few of which have been illustrated and described above. The invention may be embodied in other forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive, and the scope of the invention is therefore indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are embraced to be within their scope.

Claims (20)

1. A dressing device comprising:

a substantially rigid, elongated body adapted to receive a chest tube, the body having a first end and a second end;

a seal positionable between the body and the chest tube;

an air-impermeable flexible joint at the second end of the body, the joint having a first portion, a second portion and an internal airspace therethrough; and

a base having a first side and a second side, wherein the first side of the base is connected with the first portion of the flexible joint, and wherein the second side of the base includes an adhesive for securing the base to a patient's chest, the base providing an air-impermeable connection between the flexible joint and the patient's chest cavity;

wherein the joint is sealable between the first portion and the second portion to close the airspace therethough.

2. The dressing device ofclaim 1 wherein the flexible joint may be bent.

3. The dressing device ofclaim 1 wherein the seal is an o-ring.

4. The dressing device ofclaim 1 wherein the flexible joint and base are together removable from the body.

5. The dressing device ofclaim 4 wherein at least a portion of the flexible joint and base are together removable from the body when a chest tube has traveled a predetermined distance through the dressing device.

6. The dressing device ofclaim 4 wherein the flexible joint and base are together manually removable from the body.

7. The dressing device ofclaim 1 wherein the flexible joint is automatically sealable, between the first portion and the second portion of the flexible joint, when a chest tube has been withdrawn from a patient's chest and the chest tube travels a certain distance into the body of the dressing device.

8. The dressing device ofclaim 1 wherein the flexible joint is manually sealable, between the first portion and the second portion of the flexible joint, when a chest tube has been withdrawn from a patient's chest and the chest tube travels a certain distance into the body of the dressing device.

9. The device ofclaim 1 wherein the seal is at the first end of the body.

10. A method of preventing pneumothorax in a patient having a chest tube inserted in the patient's chest, the method comprising:

attaching to the patient's chest an air-impermeable sheath device having a body adapted to receive said chest tube, a flexible joint having a first portion and a second portion, and a base such that the flexible joint and base are removable from the body, said base, joint and body defining a sealed airspace, wherein said chest tube is positioned at least partially within said airspace;

removing the chest tube from the patient's chest and receiving the tube into the body of the sheath device;

sealing the sheath device after the chest tube is removed from the patient's chest and before the chest tube is entirely removed from the sheath device; and

removing the chest tube from the sheath device, leaving an air-impermeable dressing over the patient's chest.

11. The method ofclaim 10 wherein the joint and the body are together removable from the base of the sheath.

12. The method ofclaim 10 wherein the sheath device is sealed automatically.

13. The method ofclaim 10 wherein the sheath device is sealed manually.

14. The method ofclaim 10 wherein the joint is sealable by adhesive pre-applied to the interior of the joint when a chest tube travels a certain distance into the body of the sheath.

15. A sheath device for use on a patient having a chest tube inserted into the patient's chest cavity, the sheath device comprising:

a substantially rigid, hollow, air impermeable body configured to fit snugly around a chest tube, the body having a first end and a second end;

an air-impermeable flexible expandable seal at the first end of the body;

an air-impermeable flexible sealable joint, the joint having a first portion and a second portion, at the second end of the body; and

a base having a first side and a second side, wherein the first side of the base is connected with the first portion of the flexible joint and wherein the second side of the base includes an adhesive for securing the base to the patient's chest; the base providing an air-impermeable connection between the flexible joint and the patient's chest;

wherein the first portion of the flexible joint and the base are removable from the body and the second portion of the flexible joint such that when the first portion of the flexible joint and the base are together removed from the body and the second portion of the flexible joint, the first portion of the flexible joint and the base together form an air-impermeable dressing on the patient's chest.

16. The sheath device ofclaim 15 wherein the flexible joint is automatically sealable, between the first portion of the flexible joint and the second portion of the flexible joint, when the chest tube has been withdrawn from the patient's chest and the chest tube travels a certain distance into the body of the sheath.

17. The sheath device ofclaim 15 wherein the flexible joint is manually sealable between the first portion of the flexible joint and the second portion of the flexible joint.

18. The sheath device ofclaim 15 wherein the first portion of the flexible joint and the base are automatically removable from the body and the second portion of the flexible joint when a chest tube has been withdrawn from a patient's chest and the chest tube travels a certain distance into the body of the sheath.

19. A method of preventing pneumothorax in a patient having a chest tube inserted in the patient's chest, the method comprising:

attaching to the patient's chest an air-impermeable sheath device having a body adapted to receive said chest tube, a flexible joint having a first portion and a second portion, and a base such that the flexible joint and base are removable from the body, said base, joint and body defining a sealed airspace, wherein said chest tube is positioned at least partially within said airspace;

removing the chest tube from the patient's chest and receiving the tube into the body of the sheath device; and

automatically sealing the sheath device leaving an air-impermeable dressing over the patient's chest after the chest tube is removed from the patient's chest and before the chest tube is entirely removed from the sheath device; and

removing the second portion of the joint and the body from the first portion of the joint and the base, leaving the first portion of the joint and the base on the patient's chest as an air-impermeable dressing.

20. A method of preventing pneumothorax in a patient having a chest tube inserted in the patient's chest, the method comprising:

attaching to the patient's chest an air-impermeable sheath device having a body adapted to receive said chest tube, a flexible joint having a first portion and a second portion, and a base such that the flexible joint and base are removable from the body, said base, joint and body defining a sealed airspace, wherein said chest tube is positioned at least partially within said airspace;

removing the chest tube from the patient's chest and receiving the tube into the body of the sheath device; and

manually sealing the sheath device leaving an air-impermeable dressing over the patient's chest after the chest tube is removed from the patient's chest and before the chest tube is entirely removed from the sheath device; and

removing the second portion of the joint and the body from the first portion of the joint and the base, leaving the first portion of the joint and the base on the patient's chest as an air-impermeable dressing.

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